Recognized standard
8009 Second edition 2014-11-15
FDA recognition 9-108 · ISO · ObGyn/Gastroenterology/Urology
Key facts
| Recognition number | 9-108 |
|---|---|
| Designation | 8009 Second edition 2014-11-15 |
| Title | Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests |
| Standards developer | International Organization for Standardization |
| Specialty area | ObGyn/Gastroenterology/Urology |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 8009:2014 specifies the minimum requirements and test methods to be used for reusable diaphragms made from natural rubber and silicone rubber. These diaphragms are intended for contraceptive use. |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: